Canadian approval for Sunovion's Aptiom

USA-based drugmaker Sunovion Pharmaceuticals, a subsidiary of Japan’s Dainippon Sumitomo Pharma (TYO: 4506), has received approval from Health Canada for Aptiom (eslicarbazepine acetate) for use as a once-daily adjunctive drug (AED) to treat partial-onset seizures in patients with epilepsy who are not satisfactorily controlled with conventional therapy.

The approval is based on three Phase III randomized, double-blind, placebo-controlled, safety and efficacy trials BIA-2093-301, BIA-2093-302 and BIA-2093-304.

In these trials, treatment with Aptiom showed statistically-significant reductions in standardized seizure frequency versus placebo, and significantly more APTIOM treated patients experienced seizure frequency reduction of 50% or more from baseline. Dizziness, somnolence, headache, nausea, diplopia, vomiting, fatigue, ataxia, vision blurred, and vertigo are the most frequently reported adverse reactions in patients taking Aptiom.